Freedom Inguinal Hernia Repair System Study

Not Applicable

Terminated

• Conditions: Primary Inguinal Hernia
• Interventions: Device: Freedom ProFlor Inguinal Hernia Implant

• Registration Number: NCT01984996
• Lead Sponsor: Insightra Medical, Inc.

Brief Summary

The primary objective of this study is to evaluate patient quality-of-life (QOL) after inguinal hernia repair. "Carolinas Comfort Scale" (CCS) assessments will be held at regular intervals.

The secondary objective of the study is to follow short-term and long-term study-related complications/adverse events.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-15
• Study Start: 2013-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-06-07
• Last Update Posted: 2016-06-09
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Scheduled to undergo routine inguinal hernia repair
• Competent to give consent
• Clinically relevant inguinal hernia (classification: NYHUS I, II, IIIa)
• Defect size at operation is between 5mm and 35mm
• Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
• Primary hernia at the operative site
• Male or female
• Life expectancy of at least 12 months
• At least 18 years of age

Exclusion Criteria

• Signs of obvious local or systemic infection
• Any previous surgery on the hernia operative site
• Hernia is not in the inguinal area
• Hernia is not identified as indirect or direct
• Femoral hernias
• Known collagen disorder
• Presenting with unstable angina or NYHA class of IV
• Known Pregnancy
• Active drug user
• Recurrence of a repair by any method
• Patients with giant inguinoscrotal hernia or abdominal wall defect >35 mm in diameter - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3
• Immunosuppression, prednisone>15 mg/day, active chemotherapy
• End stage renal disease
• Abdominal ascites
• Skin infection in area of surgical field
• BMI >35
• Peritoneum cannot be closed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Freedom ProFlor Inguinal Hernia Implant	Freedom ProFlor Inguinal Hernia Implant	-

Primary Outcome Measures

Name	Time	Method
Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals	1 week, 3, 6, 9, 12, 18, 24, and 36 months.	Measure quality of life for patients undergoing inguinal hernia repair.

Secondary Outcome Measures

Name	Time	Method
Evaluate the 14-day pain and medication log	14 days	Patient will record pain score and medications for 14 consecutive days.

Trial Locations

Locations (8)

Metabolic Clinic and Research Center; 🇺🇸 Los Angeles, California, United States

Witham Health Services; 🇺🇸 Lebanon, Indiana, United States

New Hannover Regional Medical Center; 🇺🇸 Wilmington, North Carolina, United States

Istituto Clinico Sant'Ambrogio; 🇮🇹 Milano, Italy

Azienda Policlinico Umberto I; 🇮🇹 Roma, Italy

Policlinico Tor Vergata; 🇮🇹 Roma, Italy

Our Lady of the Lake Regional Medical Center; 🇺🇸 Baton Rouge, Louisiana, United States

Herz Jesu Krankenhaus GmbH; 🇦🇹 Wien, Austria